FDA Provides Additional Info on QMM Prototype Assessment Protocol Evaluation Program

Date

March 20, 2024

Category

US Regulations

Description

On January 25, 2024, the FDA announced the opportunity for a limited number of drug manufacturers to participate in this QMM Prototype Assessment Protocol Evaluation Program.

On 15 March, FDA published answers to questions that the agency has received on participation in the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The additional information being provided today includes:

• How establishments can prepare for assessments
• Who needs to be present during assessments
• Outputs from the assessments
• Opportunities for engagement after the assessments

Drug manufacturers interested in participating should request participation by March 25.